Events

Retiro De Equipo (Recall) de enGen Laboratory Automation Systems (enGen) with TCAutomation Software v2.6, v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems (an in vitro diagnostic medical device (IVD))

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ortho-Clinical Diagnostics.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00485-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-29
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00485-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Ortho clinical diagnostics (ocd) determined that, due to a software timing issue, a sample tube carrier being released in the bypass module may not be detected, potentially resulting in the next sample to be metered not advancing for processing. no error message will be posted if this occurs. the bypass module will stop processing samples indefinitely until an operator detects the issue and intervenes.
  • Acción
    Ortho-Clinical Diagnostics will provide a resolution for this issue in a future software version. In the interim, end users are requested to routinely monitor the Bypass module for stoppage due to the software timing issue. This action has been close-out on 11/02/2016.

Device

enGen Laboratory Automation Systems (enGen) with TCAutomation Software v2.6, v3.2 and v3.5 Config...
  • Modelo / Serial
    enGen Laboratory Automation Systems (enGen) with TCAutomation Software v2.6, v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems (an in vitro diagnostic medical device (IVD))Multiple affected bypass modules (product codes)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics